THE RELATIONSHIP BETWEEN CARDIAC RESYNCHRONİZATION THERAPY RESPONSE IN HEART FAILURE PATIENTS AND YKL-40 LEVELS

NCT07469137 | Active Not Recruiting

• 1 other identifier: TÜTF-GOBAEK 2025/97
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with heart failure at our clinic who routinely undergo CRT implantation will be included in the study. This decision is independent of the study. In patients included in the study, after routine placement of a coronary sinus catheter, 2 cc of blood will be drawn from this catheter without performing any additional invasive procedures on the patient. Additionally, one peripheral blood sample will be collected from the patient's routinely accessed antebrachial vein. The blood samples will be centrifuged at 4000 rpm (revolutions per minute) for 10 minutes to separate the serum and stored at -80 °C until analyzed. The demographic, clinical, laboratory, electrocardiographic, and echocardiographic data of these patients will be recorded. At the 6-month follow-up clinic visit after discharge, routine heart failure parameters, routine echocardiographic data, and routine ECG recordings will be obtained. The procedures to be performed after discharge are routine for patients who have undergone CRT implantation at our clinic, and no additional follow-up or tests will be performed for this study. After all data are recorded, statistical evaluation will be performed. Data will be reviewed through the ENLİL HBYS system. The best criteria for determining CRT response have not been clearly established. Many studies have been conducted to predict CRT response in advance. A review of the literature shows that YKL-40 levels in the blood are associated with cardiovascular diseases, but no study in the literature has shown the relationship between YKL-40 levels and CRT implantation in patients.

Conditions

Hearth Failure With Reduced Ejection Fraction (HFrEF); Cardiac Resynchronisation Therapy (CRT); Left Branch Bundle Block

Keywords

heart failure; cardiac resynchronisation therapy; left branch bundle block; reduced ejection fraction; ykl-40; CHI3L1

Outcome Measures

Primary Outcomes (1)

• The relationship between YKL-40 levels measured in patients undergoing CRT and their CRT response at 6-month follow-up

  Serum YKL-40 levels measured during cardiac resynchronization therapy (CRT) will be evaluated in conjunction with the CRT response during the patient's routine 6-month follow-up after the procedure. Patients are those for whom the decision to undergo the procedure was made independently of the study. Follow-ups are routine; there is no additional follow-up for the study.

  Baseline and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure who have been decided to undergo CRT treatment at Trakya University Cardiology Clinic

You may qualify if:

• Patients diagnosed with heart failure, with an EF ≤35, who remain in heart failure stages 2-3-4 despite optimal medical therapy, and who have LBBB and a QRS duration of at least 130 msec.
• Those who agreed to participate in the study
• Patients diagnosed with heart failure and who have been monitored, and for whom a permanent pacemaker has been decided due to the presence of a high-degree heart block

You may not qualify if:

• Patients under the age of 18
• Patients not receiving optimal medical treatment
• Those who declined to participate in the study
• Malignancy patients with an expected survival period of less than 1 year
• Patients with chronic inflammatory and rheumatological diseases

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Edirne, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Bundle-Branch Block; Heart Failure

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: August 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)